MAUDE Adverse Event Report: MC3 INC. CRESCENT BICAVAL CATHETER 32 FR; DUAL LUMEN ECMO CANNULA

Model Number	70132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Shock (2072)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of an mc3 crescent jugular dual lumen catheter, it was reported that when the customer connected the extra corporeal membrane oxygenation (ecmo) circuit tubing, there was what looked to be a tear in the cannula, near the connector.The customer changed to a new crescent, but during the exchange the tear worsened and eventually broke off outside the patient.The patient experienced hemorrhagic shock due to having to exchange the cannula.Medtronic received additional information that the procedure had been a relatively smooth cannulation up until that point.The customer's clamps were never on the affected portion of the cannula, and while it seems that it would have most likely torn during connection of the tubing to the cannula, the connection was very smooth, and the physician did not struggle to get it on or have to disconnect and reconnect.They only discovered the tear after unclamping the circuit and suddenly having blood leaking.While changing out the cannula, it continued to tear, so recannulating the new crescent was delayed.Ultimately the patient went into hemorrhagic shock and needed blood but survived ecmo and was decannulated.

• Brand Name: CRESCENT BICAVAL CATHETER 32 FR
• Common Device Name: DUAL LUMEN ECMO CANNULA
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle w; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle w; dexter MI 48130
• Manufacturer Contact: tanya pockrandt ; 2555 bishop circle w; dexter, MI 48130 ; 7349959089
• MDR Report Key: 19981326
• Report Number: 3011468686-2024-00018
• Device Sequence Number: 8141302
• Product Code: PZS
• UDI-Device Identifier: 10854916006826
• UDI-Public: (01)10854916006826(17)250630(10)2205273
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/30/2025
• Device Model Number: 70132
• Device Lot Number: 2205273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown